Aquestive Therapeutics Inc.’s oral epinephrine prodrug to treat life-threatening allergic reactions, Anaphylm, produced a faster time to maximum concentration than currently available autoinjectors in healthy adults, early pivotal phase III data show, meeting both pharmacokinetic (PK) primary and secondary endpoints.
Top-line phase II results of privately held Ocuterra Therapeutics Inc.’s novel selective small-molecule RGD integrin inhibitor, nesvategrast (OTT-166), showed it failed to meet primary and key secondary endpoints in patients with diabetic retinopathy, prompting the Boston-based company to seek strategic alternatives.
Spruce Biosciences Inc.’s results from two studies with tildacerfont in adult and pediatric classic congenital adrenal hyperplasia (CAH) spurred Wall Street to speculate – further, again – about the prospect’s odds against a drug in the works from Neurocrine Biosciences Inc.
Atrogi AB is raising a €30 million to €35 million (US$32.9 million to $38.4 million) series B round after announcing positive clinical data for ATR-258, a novel beta-2 adrenergic receptor agonist that is being lined up as a potential first-in-class insulin-independent treatment for type 2 diabetes.
Silence Therapeutics plc disclosed positive top-line 36-week data from the Alpacar-360 phase II study with zerlasiran, a short interfering RNA gene muter that targets lipoprotein(a), but also said Mallinckrodt plc has quit development of a separate prospect.
Japanese researchers from Chiba University are spearheading new research into Peace of Mind Co. Ltd.’s portable Angel Touch device (AT-04), approved for neurological disorders, to treat endometriosis-related pain.
With a second batch of phase Ib data from the trial testing RGLS-8429 in hand from Regulus Therapeutics Inc., Wall Street is looking forward to results from the third cohort in midyear and weighing prospects with the compound in autosomal dominant polycystic kidney disease. Screening of the fourth cohort will start during the second quarter. Meanwhile, the company has begun to mull a pivotal phase II trial that would launch in the middle of next year, and may help with accelerated approval by the U.S. FDA.
It’s the end of the development line for Acadia Pharmaceuticals Inc.’s main asset, pimavanserin. The company said it won’t conduct any more clinical studies on the selective serotonin inverse agonist and antagonist targeting 5-HT2A receptors after a phase III fail in schizophrenia.
One topic at the 31st Conference on Retroviruses and Opportunistic Infections (CROI 2024) held in Denver this month was that resistance to antiretroviral therapy (ART) has become a public health problem for people living with HIV. Without a vaccine or a cure, these patients depend on treatments that suppress viremia by preventing the virus from replicating. They are lifelong treatments and, until new advances succeed in eradicating the virus from reservoirs, the only option available.
After spending 20 years at Novartis, Radiopharm Theranostics Ltd. CEO Riccardo Canevari told BioWorld that when he joined Radiopharm he wanted to focus on something different within radiopharmaceuticals where no one was playing. “I believe these new modalities are at the beginning of their potential, much like in the immuno-oncology space years ago. That’s a nice place to be,” he said, but it’s not only about competition, it’s also about understanding what other companies are doing and if there is a disease area or a mechanism of action that is not being explored, he said.
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